氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011465973146587814666601466228146573814660950.03
210.721434155143434214342480.01
单位质量响应值RSD%判断
133160.31133791.790.34数据可信
供试品溶液-2024041821批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1426091-42609128.30427.165.2628.3027.165.25
2388649-38864925.81725.82
3400719-40071926.61926.62
4380975-38097525.30725.31
5426600-42660028.33828.34
6429875-42987528.55628.56
480min1796757-79675752.92752.532.8152.9752.572.81
2782301-78230151.96652.01
3816067-81606754.20954.25
4751230-75123049.90349.94
5799997-79999753.14253.18
6798621-79862153.05153.09
720min11165225-116522577.40378.083.1277.5378.203.11
21191147-119114779.12579.24
31218446-121844680.93981.06
41113488-111348873.96674.08
51198896-119889679.64079.76
61165276-116527677.40777.53
960min11465839-146583997.37299.382.0497.6199.622.04
21474044-147404497.91798.15
31542614-1542614102.472102.72
41477233-147723398.12998.35
51494374-149437499.26899.51
61522710-1522710101.150101.39
1200min11524876-1524876101.294100.691.03101.68101.071.03
21518640-1518640100.880101.26
31535892-1535892102.026102.42
41499136-149913699.58499.96
51495623-149562399.35199.74
61520364-1520364100.994101.38
1440min11515414-1515414100.66699.981.02101.20100.511.02
21510116-1510116100.314100.85
31523975-1523975101.234101.78
41488013-148801398.84599.37
51485723-148572398.69399.23
61506971-1506971100.105100.65
极限11510940-1510940100.36899.791.08101.06100.481.08
21506531-1506531100.075100.76
31523144-1523144101.179101.88
41484314-148431498.60099.27
51481580-148158098.41899.11
61507030-1507030100.109100.80
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011464087146347114635371463288146254214633850.04
210.721442754144210114424280.04
单位质量响应值RSD%判断
132914.17134554.850.87数据可信
供试品溶液-2024041821批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1412272-41227227.33427.0212.8827.3327.0212.87
2407788-40778827.03727.04
3454340-45434030.12330.12
4307052-30705220.35820.36
5419795-41979527.83327.83
6443509-44350929.40529.41
480min1801821-80182153.16251.3513.6553.2051.3913.64
2735812-73581248.78548.83
3797295-79729552.86252.91
4583145-58314538.66338.69
5876192-87619258.09358.13
6852455-85245556.51956.56
720min11170420-117042077.60175.1812.1077.7275.3012.10
21046091-104609169.35769.47
31182257-118225778.38578.51
4901099-90109959.74459.83
51270531-127053184.23884.37
61232967-123296781.74881.88
960min11429748-142974894.79496.026.6895.0396.256.69
21444643-144464395.78296.00
31467579-146757997.30397.54
41276137-127613784.61084.79
51512429-1512429100.276100.53
61559087-1559087103.370103.62
1200min11513735-1513735100.363100.341.18100.74100.721.18
21512284-1512284100.267100.63
31497407-149740799.28099.67
41507455-150745599.946100.25
51502180-150218099.597100.00
61547355-1547355102.592103.00
1440min11499098-149909899.39299.701.1499.92100.221.14
21504610-150461099.758100.27
31487690-148769098.63699.17
41503398-150339899.678100.13
51491970-149197098.92099.47
61535833-1535833101.828102.39
极限11499583-149958399.42599.561.16100.10100.241.17
21500087-150008799.458100.12
31484706-148470698.43899.12
41500310-150031099.473100.08
51490684-149068498.83599.54
61534753-1534753101.756102.47
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